1. Field of the Disclosure
The disclosure relates generally to delayed release formulations of cysteamine and pharmaceutically acceptable salts thereof, and related methods of making and treatment, e.g. treatment of cystinosis and other metabolic and neurodegenerative diseases including non-alcoholic fatty liver disease (NAFLD), Huntingon's disease, Parkinson's disease, Rett Syndrome and others, use as free radical and radioprotectants, and as hepto-protectant agents. More particularly, the disclosure relates to enteric coated beads comprising cysteamine or a pharmaceutically acceptable salt thereof.
2. Brief Description of Related Technology
Cystinosis is a rare, autosomal recessive disease caused by intra-lysosomal accumulation of the amino acid cystine within various tissues, including the spleen, liver, lymph nodes, kidney, bone marrow, and eyes. Nephropathic cystinosis is associated with kidney failure that necessitates kidney transplantation. A specific treatment for nephropathic cystinosis is the sulfhydryl agent, cysteamine. Cysteamine has been shown to lower intracellular cystine levels, thereby reducing the rate of progression of kidney failure in children.
An enterically-coated cysteamine composition has been described, for increasing delivering of cysteamine to the small intestine and resulting in less frequent dosing compared to non enteric-coated cysteamine.